A Feasibility Study to Evaluate the Safety of the KNP-1000 Apheresis System in Severe Preeclampsia

Официальное название

A Feasibility Study to Evaluate the Safety of the KNP-1000 Apheresis System in Patients With Preeclampsia With Severe Features

Обзор

The study will primarily evaluate safety of the KNP-1000 apheresis system for pregnant women and their fetuses diagnosed with preeclampsia with severe features between 23- and 32-weeks' gestation (very preterm).

Вмешательства

• Устройство KNP-1000 Apheresis System
  sFlt-1 is removed from the participants' plasma through treatment.

Первичные конечные точки

• Antepartum maternal and fetal device-related serious adverse events [Срок оценки: Until date of delivery]
• Postpartum maternal and neonatal device-related serious adverse events [Срок оценки: Following delivery until end of follow-up (2 years)]
• Maternal, fetal, and neonatal mortality [Срок оценки: Until end of follow-up (2 years)]
• Obstetric complication [Срок оценки: Until discharge or 6 weeks after delivery, whichever occurs first]
• Fetal complications [Срок оценки: Until date of delivery]
• Neonatal morbidities associated with premature delivery [Срок оценки: Following delivery until discharge or 6 weeks after delivery, whichever occurs first]
• Neonatal intensive care unit (NICU) admissions [Срок оценки: From date of NICU admission until the date of NICU discharge, assessed up to 24 months]

Вторичные конечные точки (12)

• Prolongation of pregnancy [Срок оценки: Until date of delivery]
• Maternal systolic blood pressure [Срок оценки: Until discharge or 6 weeks after delivery, whichever occurs first]
• Maternal diastolic blood pressure [Срок оценки: Until discharge or 6 weeks after delivery, whichever occurs first]
• Maternal proteinuria [Срок оценки: Until discharge or 6 weeks after delivery, whichever occurs first, an average of 4 months]
• Gestational age of the neonate at delivery [Срок оценки: At date of delivery]
• Weight of neonate at delivery [Срок оценки: At date of delivery]
• Amniotic fluid volume [Срок оценки: Until the date of delivery, an average of 3 months]
• Fetal umbilical artery flow [Срок оценки: Until the date of delivery, an average of 3 months]
• Uterine artery flow [Срок оценки: Until the date of delivery, an average of 3 months]
• Maternal low-density lipoprotein cholesterol (LDL-C) levels [Срок оценки: Until discharge or 6 weeks after delivery, whichever occurs first, an average of 4 months]
• Fetal growth restriction [Срок оценки: Until date of delivery]
• APGAR scores [Срок оценки: At date of delivery]

Критерии участия

Критерии включения

A participant is deemed suitable for inclusion in the investigation if she meets the following criteria:

• Pregnant woman ≥ 23 0/7 and \< 32 0/7 weeks gestation, aged 18 to 45 years, hospitalized for preeclampsia at time of enrollment.
• Severe hypertension ever defined by resting systolic BP ≥ 160 mm Hg and/or diastolic BP ≥ 110 mm Hg on two occasions measured at least 4 hours apart.
• Proteinuria, defined as ≥ 300 mg protein in a 24-hour urine collection or ≥ 0.3 protein/creatinine ratio.
• Provision of signed and dated informed consent form.

Критерии исключения

A participant will be excluded from the investigation if any of the following maternal or fetal criteria are met.

Maternal Exclusion Criteria:

• Documented history of chronic hypertension, defined as systolic BP ≥ 140mmHg and/or systolic BP ≥ 90 mmHg before pregnancy or prior to 20 weeks of gestation.
• Documented history of proteinuria prior to pregnancy or prior to 20 weeks of gestation.
• Taking any form of angiotensin cascade blocker or angiotensin-converting enzyme (ACE) inhibitor at time of enrollment.
• Documented history of cardiac impairments including uncontrolled arrhythmia, unstable angina, decompensated congestive heart failure, or valvular disease.
• Actively receiving therapeutic anticoagulation therapy or within the therapeutic window after ceasing anticoagulation therapy at the time of enrollment.
• Any condition which, in the opinion of the Investigator, would necessitate immediate delivery within 24 hours.
• Signs or history of cerebral nervous system dysfunction, including seizures, cerebral edema (previously confirmed by computed tomography scan or magnetic resonance imaging per medical records).
• Confirmed or suspected diagnosis of pulmonary edema at time of enrollment.
• Diagnosis of HELLP syndrome.
• Thrombocytopenia (platelet count \< 100,000/mm3) at time of enrollment.
• Anemia defined as hemoglobin \< 8 g/dL at time of enrollment.
• Absent or reverse flow on umbilical Doppler ultrasound exam at the time of screening, or documented history of negative or reverse flow during the current gestation period.
• Diagnosis of placenta previa during the current gestation period.
• Preterm labor at or before time of screening.
• Documented medical history of active hepatitis B virus, hepatitis C virus (HCV), syphilis, tuberculosis infection, or human immunodeficiency virus (HIV) positive status.
• Any condition that the Investigator deems a risk to the study participant or fetus in completing the investigation.
• Hypersensitivity to dextran sulfate cellulose or heparin.
• Multiple gestation.
• Documented history of familial hypercholesterolemia.
• Suspicion or diagnosis of placental abruption during the current gestation.
• Patients who have received the drug treatment not recommended by the American College of Obstetricians and Gynecologists (ACOG) practice bulletin Gestational Hypertension and Preeclampsia (the clinical management guidelines) within 6 months prior to enrollment.
• Patients who have participated in another clinical trial within 6 months prior to enrollment.

Fetal Exclusion Criteria:

• Documented record of chromosomal anomalies.
• Identifiable structural fetal abnormalities present at time of screening or a record of such abnormalities prior to enrollment.
• Oligohydramnios, defined as Amniotic fluid index (AFI) less than 5 cm when measured using the four-quadrant method at time of enrollment.
• Fetal growth restriction (FGR) defined as estimated fetal weight (EFW) below the 5th percentile for gestational age.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06580405 · KNP-1000-US01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗